| CTRI Number |
CTRI/2010/091/000595 [Registered on: 18/06/2010] |
| Last Modified On: |
30/09/2014 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
This study is to check the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with type 2 diabetes |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-Blind, 3-Arm Parallel-Group, 2-Year (104-Week), Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-28431754 Compared With Glimepiride in the Treatment of Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled on Metformin Monotherapy |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 28431754DIA3009 version INT 3 dated 8 Oct 2010 |
Protocol Number |
| NCT00968812 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Not Applicable |
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
400080
Other |
| Phone |
|
| Fax |
|
| Email |
pjoshi@its.jnj.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrJitendra R Dixit MD |
| Designation |
Head Global Clinical Operations India |
| Affiliation |
Global Clinical Operations India |
| Address |
Correspondence address:
Johnson and Johnson Ltd.,
Global Clinical Operations
501 Arena Space Behind Majas Bus Depot Off J.V. Link Road Jogeshwari East Mumbai
Registered address:
Johnson and Johnson Limited
L.B.S. Marg Mulund West Mumbai 400080
Mumbai
MAHARASHTRA
400060
India |
| Phone |
02266646464 |
| Fax |
02266718200 |
| Email |
jdixit@its.jnj.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Jitendra Dixit |
| Designation |
Head Global Clinical Operations India |
| Affiliation |
Global Clinical Operations India |
| Address |
Correspondence address:
Johnson and Johnson Ltd.,
Global Clinical Operations
501 Arena Space Behind Majas Bus Depot Off J.V. Link Road Jogeshwari East Mumbai
Registered address:
Johnson and Johnson Limited
L.B.S. Marg Mulund West Mumbai 400080
Mumbai
MAHARASHTRA
400060
India |
| Phone |
02266646464 |
| Fax |
02266718200 |
| Email |
jdixit@its.jnj.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Janssen Research & Development, L.L.C. 920 Route 202 PO box 300 Raritan NJ 08869 |
|
Primary Sponsor
Modification(s)
|
| Name |
Johnson Johnson Pharmaceutical Research Development LLC |
| Address |
920 Route 202, P.O. Box 300
Raritan, NJ 08869, USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
Argentina
Bulgaria
Canada
Costa Rica
Denmark
Finland
Germany
India
Israel
Mexico
Norway
Philippines
Poland
Romania
Russian Federation
Slovakia
Ukraine
United States of America |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Satish Mahajan |
AVBR Hospital |
Affiiated to JN Medical College,Swangi-Meghe, Wardha-442004
Wardha
MAHARASHTRA |
07152-287701
07152-287714
mahajandr@rediffmail.com |
| Dr. Vaishali Deshmukh |
Deenanath Mangeshkar Hospital |
Dept. of Endocrinology,Erandawane-411004
Pune
MAHARASHTRA |
9850811450
020-40151668
docvaishali@yahoo.com |
| Dr. Nagajyothi Borra |
Diabetomics India Pvt. Ltd |
6-3-349/17-B, ,Hindi Nagar, Behind Panjagutta Saibaba Temple,Banjara Hills, -500034
Hyderabad
ANDHRA PRADESH |
040-55341355
040-23357111
diabtrials@gmail.com |
| Dr. Veerasamy Seshiah |
Dr. V. Seshiah Diabetes Research Institute & Dr. Balaji Diabetes Care Centre |
#729, P.H. Road, Aminjikarai,,-600029
Chennai
TAMIL NADU |
044-26641414
044-26640660
vseshiah@gmail.com |
| Dr. Pramod Gandhi |
Gandhi's Research Institute |
C-1, Shreevardhan Complex,Wardha Road,Ramdaspeth-440010
Nagpur
MAHARASHTRA |
0712-2460302
0712-2441749
drpdgandhi1@yahoo.co.in |
| Dr. Sunil Ambulkar |
Institute of Clinical Endocrinology & Diabetes Care Unit |
Bajaj Nagar,,-440010
Nagpur
MAHARASHTRA |
9823037686
0712-2249522
endodoc10@hotmail.com |
| Dr. Satyanarayana Srikanta |
Jnana Sanjeevini Medical Center, |
#2, 1A Cross, Marenahalli,J P Nagar, Phase 2,-560078
Bangalore
KARNATAKA |
080-26493040
080-26493050
samatvam@vsnl.com |
| Dr. Balamurugan Ramanathan |
Kovai Diabetes Speciality Center and Hospital |
15,Vivekananda Road,Ramnagar-641009
Coimbatore
TAMIL NADU |
9842244881
0422-4377714
balamurugan_dr@hotmail.com |
| Dr. Paramesh Shamanna |
Medisys Clinisearch India Pvt. Ltd., |
Bangalore Diabetes Centre,,4c-426, 4th Cross, 2nd Block, Kalyan Nagar-560043
Bangalore
KARNATAKA |
+91-80-25425396
+91-80-25421333
dr_paramesh@hotmail.com |
| Dr. Rakesh Kumar Sahay |
Osmania General Hospital |
Department of Endocrinology, 2nd Floor,,Golden Jubillee Block, Afzalganj-500012
Hyderabad
ANDHRA PRADESH |
09849597507
040-24651667
sahayrk@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Central India Medical Research Ethics Committee |
Approved |
| CLINICOM |
Approved |
| Ethics Committee - Dr. V. Seshiah Diabetes Research Institute |
Approved |
| Global Health Concern Ethics Committee |
Approved |
| Institutional Ethics Committee - Datta Meghe Institute of Medical Sciences University |
Approved |
| Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital |
Approved |
| Medisys Clinisearch Ethical Review Board |
Approved |
| Osmania Medical College - Ethics Committee |
Approved |
| Science For Health |
Approved |
| The Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 diabetes mellitus (T2DM), |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Glimepiride (oral) |
starting oral dosage of 1mg increased to max of 6 or 8 mg once daily for 104 weeks |
| Intervention |
JNJ-28431754 100 or 300 mg orally |
100 or 300 mg once daily orally for 104 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients must have a diagnosis of type 2 diabetes
Body mass index (BMI) more than or equal to 22 to less than or equal to 45 kg per sqm at screening
Patients must be taking a stable dosage of metformin as monotherapy at screening
Patients must have a HbA1c between more than or equal to 7percent and less than or equal to 9.5percent at Week 2
Patients must have a fasting plasma glucose (FPG) less than or equal to 270 mgperdL ie 15 mmolperL at Week -2
|
|
| ExclusionCriteria |
| Details |
Patients having prior exposure or known contraindication or suspected hypersensitivity to JNJ-28431754, glimepiride, or metformin
History of diabetic ketoacidosis or type 1 diabetes mellitus
History of pancreas or beta-cell transplantation
History of active proliferative diabetic retinopathy
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant
Taken thiazolidinedione therapy in the past 16 weeks before screening |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary efficacy endpoint is the change in Hemoglobin A1c |
From baseline through Week 52 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The percent change in body weight |
From baseline through Week 52 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1281"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
18/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
28/08/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet availble |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. This is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of JNJ-28431754 compared with glimepiride in patients with T2DM, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. The primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin A1c (HbA1c) from baseline. The patients will receive capsules taken by mouth of JNJ-28431754 (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.
We intend to recruit 200 patients from India and first patient consented in India is planned on 21 June 2010.
|